U.S. patent application number 13/353671 was filed with the patent office on 2012-08-09 for system and method for packaging and mixing multi-part medicant.
Invention is credited to Jeffry S. Melsheimer.
Application Number | 20120201095 13/353671 |
Document ID | / |
Family ID | 46600554 |
Filed Date | 2012-08-09 |
United States Patent
Application |
20120201095 |
Kind Code |
A1 |
Melsheimer; Jeffry S. |
August 9, 2012 |
SYSTEM AND METHOD FOR PACKAGING AND MIXING MULTI-PART MEDICANT
Abstract
Disclosed is a system for mixing and dispensing bone cement. The
system includes a flexible bag containing isolated liquid and
powder components that are reactive with each other to form bone
cement and a mixing device that has first and second primary
pressure surfaces and first and second secondary curved pressure
surfaces. The system allows the bag to attach to the first and
second secondary pressure surfaces. The system is operated such
that the first primary pressure surface exerts force on the bag
against the first secondary pressure surface and the second primary
pressure surface exerts force on the bag against the second
secondary pressure surface. Relative movement of the primary
pressure surfaces with respect to the bag causes mixing of the
components within the bag.
Inventors: |
Melsheimer; Jeffry S.;
(Springville, IN) |
Family ID: |
46600554 |
Appl. No.: |
13/353671 |
Filed: |
January 19, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61440610 |
Feb 8, 2011 |
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Current U.S.
Class: |
366/342 ;
206/219 |
Current CPC
Class: |
B01F 2215/0029 20130101;
B01F 11/0065 20130101 |
Class at
Publication: |
366/342 ;
206/219 |
International
Class: |
B01F 13/00 20060101
B01F013/00; B65D 25/08 20060101 B65D025/08 |
Claims
1. A container system for packaging and mixing a first component
and a second component reactive with each other to form a bone
cement, the container system comprising: a substantially flat and
flexible bag defining a first chamber and a second chamber; a first
flowpath defined by said bag and connecting said first and second
chambers; a second flowpath defined by said bag and connecting said
first and second chambers, wherein said first flowpath is located
in a separate region of said bag from said second flowpath.
2. The container system of claim 1, further comprising a removable
divider constructed and arranged to isolate said first chamber from
said second chamber.
3. The container system of claim 2, wherein said first chamber is
constructed and arranged for containing a liquid first component
and said second chamber is constructed and arranged for containing
a powder second component and said divider is constructed and
arranged to isolate the first and second components from each
other.
4. The container system of claim 1, wherein said bag comprises
fused first and second flexible sheets wherein said first and
second flowpaths are defined by fused interior surfaces of said
first and second sheets.
5. The container system of claim 1, wherein the cross-sectional
area of said first flowpath narrows before feeding into said second
chamber and the cross-sectional area of said second flowpath
narrows before feeding into said first chamber.
6. The container system of claim 1, further comprising: an first
expulsion tap on a first edge of the bag; and an second expulsion
tap on a second edge of the bag.
7. The container system of claim 6, wherein said first and second
edges are positionally opposed.
8. The container system of claim 6, wherein said first expulsion
tap is fluidly connected with said first chamber and said second
expulsion tap is fluidly connected with said second chamber.
9. A system for mixing a first component and a second component to
form and dispense a medicament, said system comprising: a flexible
bag containing isolated first and second components reactive with
each other to form the medicament; a mixing device comprising first
and second primary pressure surfaces and first and second secondary
pressure surfaces; wherein said flexible bag is attached to said
first and second secondary pressure surfaces, wherein said first
primary pressure surface exerts force on said bag against said
first secondary pressure surface and said second primary pressure
surface exerts force on said bag against said second secondary
pressure surface, wherein said first and second secondary pressure
surfaces are curved and wherein relative movement of said primary
pressure surfaces with respect to said bag causes mixing of the
components within said bag.
10. The system of claim 9, wherein said flexible bag is attached to
said first and second secondary pressure surfaces by elongated
members fixed to the ends of said bag and elongated channels in
said secondary pressure surfaces whereby said elongated members are
constructed and arranged to fit into and be retained by said
elongated channels.
11. The system of claim 9, wherein said primary pressure surfaces
are substantially cylindrical.
12. The system of claim 11, wherein said secondary pressure
surfaces are substantially cylindrical.
13. The system of claim 11, further comprising a first swivel arm
rotatably connected at a first axis line of said first primary
pressure surface and at a second axis line of said first secondary
pressure surface.
14. The system of claim 13, wherein said first swivel arm has a
length substantially similar to the sum of the radii of said
primary and secondary pressure surfaces such that when said first
swivel arm rotates, a substantially constant pressure force is
applied to said bag between said primary and secondary pressure
surfaces.
15. The system of claim 9, wherein said first and second secondary
pressure surfaces are rotatable relative to said first and second
primary pressure surfaces.
16. The system of claim 15, further comprising a mechanical control
means to rotate said first secondary pressure surface about its
axis, wherein said mechanical control means is selected from the
group consisting of gears, chains, belts, and kinematic links.
17. The system of claim 16, whereby movement of said first primary
pressure surface causes mixing of the components within said
bag.
18. A method of mixing and expelling medicament comprising: fixing
a substantially flat and flexible bag having a first and second
components reactive with each other to form bone cement to a mixing
device including first and second primary pressure surfaces and
first and second secondary pressure surfaces wherein the bag is
attached to each of the secondary pressure surfaces, whereby the
secondary pressure surfaces are curved; and actuating the mixing
device to cause relative movement between the bag and the first
primary pressure surface wherein the first primary pressure surface
creates a pinch point on the bag between the first primary pressure
surface and the first secondary pressure surface causing the
components within the bag to move from a first chamber of the bag
to a second chamber of the bag.
19. The method of claim 18, further comprising actuating the mixing
device to cause relative movement between the bag and the second
primary pressure surface wherein the second primary pressure
surface creates a pinch point on the bag between the second primary
pressure surface and the second secondary pressure surface causing
the components within the bag to move from the second chamber of
the bag to the first chamber of the bag.
20. A device for sealing and subdividing a flexible bag,
comprising: a first elongated member having a rounded pressure
surface and a maximum width, a substantially rigid, second
elongated member constructed and arranged to fit around said
rounded pressure surface and the flexible bag wrapped around said
rounded pressure surface, wherein said second member has an opening
width that is less than said maximum width.
Description
REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/440,610, filed Feb. 8, 2011, which is hereby
incorporated by reference.
BACKGROUND
[0002] The present disclosure concerns a device for mixing
components of a medicament together in a practical, safe and
convenient way. In particular, the disclosure includes a bone
cement mixer for mixing liquid and powder components reactive with
each other to form bone cement in a pre-filled container.
[0003] Bone cements are used in a variety of orthopedic therapeutic
situations, for example to secure bone to bone or to a prosthetic,
and generally consists of a liquid component and a powder
component. Bone cement sets up over time, so it is desirable to mix
the components as close to the time of use as possible in order to
complete any procedures before the bone cement cures. Therefore it
is common for bone cement to be mixed in the operating theatre just
prior to application of the bone cement. The components must be
thoroughly mixed in order to create effective cement. However,
sometimes it is difficult to achieve a uniform mixture of cement by
most conventional mixing methods, such as by manually mixing in a
bowl, or by hand manipulation of a bag containing both components.
Additionally, the chemical reaction from the mixing process
produces undesirable fumes that are troublesome.
SUMMARY
[0004] Disclosed is a bone cement mixer for mixing liquid and
powder components in a pre-filled flexible container. The
components are at first isolated in a divided bag. The mixing
device is lightweight and easily transported. The mixing device has
active surfaces that apply pressure to the outside of the container
and cause uniform mixing of the components within the container.
Optional flowpaths in the flexible container can be shaped to
facilitate mixing of the components. An optional tap on one edge of
the flexible container allows gas to be purged. An optional tap on
another edge of the flexible container allows the bone cement
mixture to be dispensed.
BRIEF DESCRIPTION OF THE FIGURES
[0005] FIG. 1 is a perspective view of an embodiment of a system
for packaging and mixing a multi-part medicament including a mixing
device and a flexible container.
[0006] FIG. 2 is an assembly view of the FIG. 1 mixing device.
[0007] FIG. 3 is a perspective view of a roller, a component of the
FIG. 2 assembly.
[0008] FIG. 4 is a perspective view of a drum, an alternative
embodiment of a drum of the FIG. 2 assembly.
[0009] FIG. 5 is a top plan view of the mixing device of FIG.
1.
[0010] FIG. 6 is a bottom perspective view of a swivel arm that
couples the FIG. 3 roller and the FIG. 4 drum as shown in the FIG.
2 assembly.
[0011] FIG. 6A is a bottom plan view of the FIG. 6 swivel arm.
[0012] FIG. 7 is a perspective view of a biasing member positioned
between the FIG. 6 swivel arm and the FIG. 4 drum.
[0013] FIG. 8 is a perspective view of a swivel mounting mechanism
that couples the FIG. 4 drum and the FIG. 1 mixing device as shown
in the FIG. 2 assembly.
[0014] FIG. 9 is a perspective view of a biasing member that
applies relative force between the FIG. 1 mixing device and the
FIG. 8 swivel mounting mechanism.
[0015] FIG. 10 is perspective view of one embodiment of a flexible
container partitioned into two separated compartments by a
divider.
[0016] FIG. 11 is a bottom perspective view of the FIG. 1
mixing.
[0017] FIG. 12 is a perspective view of several components of a
driving mechanism, including a motor, a gear reducer, and a
crank.
[0018] FIG. 13 is a perspective view of a crank connecting arm for
the FIG. 11 motion-driving mechanism.
[0019] FIG. 14 is a bottom plan view of the FIG. 1 mixing
device.
[0020] FIG. 15 is a partial side elevational view of the FIG. 1
mixing device showing the interconnections of the drums and rollers
with the swivel arms, crank, and crank connecting arm.
[0021] FIG. 16A is a top perspective view of the FIG. 1 mixing
device.
[0022] FIG. 16B is a top perspective view of the FIG. 16A mixing
device with the FIG. 6 swivel arms biased in a loading
configuration ready to receive the FIG. 10 flexible container.
[0023] FIG. 16C is a top perspective view of the FIG. 16B mixing
device loaded with the FIG. 10 flexible container.
[0024] FIG. 16D is a top perspective view of the FIG. 16C mixing
device with the FIG. 6 swivel arms unrestrained and applying force
to the FIG. 10 flexible container.
[0025] FIG. 17A is a top plan view of the FIG. 16C
configuration.
[0026] FIG. 17B is a top plan view of the FIG. 16D
configuration.
[0027] FIG. 17C is a top plan view of the FIG. 17B mixing device
illustrating rotation of the drums.
[0028] FIG. 18 is a cross-sectional view of an alternative
embodiment of the FIG. 10 flexible container.
[0029] FIG. 19A is a side elevational view of the FIG. 18 flexible
container with FIG. 3 rollers illustrating one arrangement during
mixing.
[0030] FIG. 19B is a side elevational view of the FIG. 18 flexible
container with FIG. 3 rollers illustrating another arrangement
during mixing.
[0031] FIG. 20A is a side elevational view of the FIG. 18 flexible
container with FIG. 3 rollers illustrating another arrangement
during venting.
[0032] FIG. 20B is a side elevational view of the FIG. 18 flexible
container with FIG. 3 rollers illustrating another arrangement
during dispensing.
[0033] FIG. 21 is a perspective view of an alternative embodiment
of a divider.
[0034] FIG. 22 is a perspective view of an alternative embodiment
of the FIG. 10 flexible container partitioned by the FIG. 21
divider.
[0035] FIG. 23A is a cross-sectional view of another alternative
embodiment of the flexible container.
[0036] FIG. 23B is a cross-sectional view of yet another
alternative embodiment of the FIG. 10 flexible container.
[0037] FIG. 24 is a cross-sectional view of still another
alternative embodiment of the FIG. 10 flexible container.
[0038] FIG. 25 is a cross-sectional view of a further alternative
embodiment of the FIG. 10 flexible container.
DETAILED DESCRIPTION
[0039] For the purpose of promoting an understanding of the claims,
reference will now be made to certain embodiments and possible
variations thereof and specific language will be used to describe
the same. It should nevertheless be understood that no limitation
of the scope of this disclosure and the claims is thereby intended,
and that such alterations, further modifications and further
applications of the principles described herein are contemplated as
would normally occur to one skilled in the art to which the
disclosure relates. In several figures, where there are the same or
similar elements, those elements are designated with the same or
similar reference numerals.
[0040] FIG. 1 illustrates a system for packaging and mixing a
multi-part medicament including bone cement mixer 99 which includes
support structure 100, drum 110a, drum 110b, swivel mounting
mechanism 127, roller 120a, roller 120b, swivel arms 122a-d, swivel
arms 128a and 128b, and flexible container 130. As illustrated,
roller 120a is arranged to rotate radially around drum 110a, and
roller 120b is arranged to rotate radially around drum 110b. Drum
110a is rotatably coupled to support structure 100. Drum 110b is
rotatably mounted to swivel mounting mechanism 127 which is
pivotally coupled to support structure 100.
[0041] As described more fully below, flexible container 130 is
positioned in bone cement mixer 99 such that contact on flexible
container 130 is made between one or more of the following: between
drum 110a and roller 120a, between drum 110b and roller 120b, and
between drum 110a and drum 110b.
[0042] Roller 120 may refer to either and/or both roller 120a and
roller 120b, and in various embodiments can be any pressure surface
suitable to apply pressure to a flexible container and against a
secondary pressure surface including a non-rotating pressure
surface (not illustrated). In this context, rollers 120 serve as
primary pressure surfaces that keep the bolus of bag contents
biased together as the bag is shifted from one extreme to the
other. Similarly, drum 110 refers to either drum 110a or drum 110b,
and can be any curved pressure surface suitable for a primary
pressure surface to apply pressure to a flexible container. In this
context, drum 110 serves as a secondary pressure surface.
[0043] Drum 110b is rotatably coupled to swivel arms 128a and 128b,
which allow both rotational and angular translational motion of
drum 110b with respect to support structure 100. Rotatable mounting
support 127a laterally supports swivel arms 128a and 128b and
rotatably mounts swivel arms 128a and 128b to support structure
100. In each reference to rotatable motion in this description,
such rotatable motion can be facilitated by any of several
non-enumerated means known to persons skilled in the art, such as
axles, bushings, or bearings.
[0044] Biasing member 126 (FIG. 5) biases rollers 110a and 110b
together which may form a restriction therebetween that may
generate shear resistance mixing. FIG. 3 illustrates roller 120 as
a cylindrical shape, which can embody both roller 120a and 120b as
illustrated in FIG. 2. In other embodiments, roller 120 could be
shaped as an elongated non-rotational strip and formed from a
compliant material. Roller 120 could also be a solid, non-rotating
plough-type structure. In other embodiments, roller 120 can be
formed from a rigid material. Roller 120 can also be formed from a
compliant material. Alternatively, roller 120 could be formed from
a rigid material and covered in a compliant material.
[0045] FIG. 3 shows rotatable connection point 121, which could be
a center bore that can support an axle. Alternatively, rotatable
connection point 121 could be a shallow hole defining a bushing to
support other rotatable connection means such as a stub axle. FIG.
2 shows roller 120a rotatably connected to swivel arms 122a and
122b by axle 129a. In the illustrated embodiment, roller 120a has a
length shorter than axle 129a to create a separation distance
between the bottom surface of swivel arm 122a and the top surface
of roller 120a. In other embodiments, roller 120a and axle 129a
could be unitarily constructed as one piece.
[0046] Drum 110, as illustrated in FIG. 2 is a cylindrically shaped
form. FIG. 4 illustrates an alternative embodiment of drum 110
including a slightly convex curvature along its length. However, it
will be apparent to one skilled in the art that other suitable
shapes could suffice. For example, drum 110 could have a generally
half-moon profile (as viewed from above) instead of a generally
circular profile.
[0047] Drum 110 includes rotatable connection point 112, which in
the illustrated embodiment is a center bore running axially through
the drum that is constructed and arranged to support an axle. In
other embodiments (not illustrated), rotatable connection point 112
could be a shallow hole defining a bushing to support any other
rotatable connection means such as a stub axle. In yet other
embodiments, drum 110 may incorporate an integral axle.
[0048] In the embodiment illustrated in FIG. 4, on drum 110 surface
117a is offset from surface 116a by a separation distance that
generally coincides with the separation distance between the top
surface of roller 120a and the bottom surface of swivel arm 122a.
The bottom of drum 110 has surface 117b and surface 116b, which are
also offset by a separation distance similar to that described for
the top surfaces 116a and 117a. The offset distance between
surfaces 117a and 116a and surfaces 117b and 116b could be achieved
by manufacturing a unitary piece to create drum 110. Alternatively,
drum 110 could be integrally created from two or more pieces
attached together.
[0049] Still referring to FIG. 4, drum 110 (in both illustrated
embodiments) includes biasing member connection point 113 on
surface 117a. Drum 110 also includes mounting channel 111, which,
as described below, is operable receive container 130 to couple
flexible container 130 to drum 110. Mounting channel 111 terminates
near the bottom of drum 110 at channel end 118. Connection point
114, on surface 117b, provides a rotatable connection point for
connecting arm 105 (FIG. 13) to drum 110.
[0050] In any embodiment, drum 110 may be constructed from a
compliant material. Alternatively, drum 110 could be rigidly
constructed, and pressure surface 115 could be covered with a
compliant material. Pressure surface 115 could be generally
straight and cylindrical or tapered from the top and bottom as
shown in FIG. 4.
[0051] Similarly, roller 120 could be generally straight and
cylindrical (FIG. 3) or tapered from the top and bottom (not
illustrated) similarly to drum 110 (FIG. 4). In the illustrated
embodiment (FIG. 1), the space between the surfaces of rollers 120a
and 120b and drums 110a and 110b may be constructed and arranged to
be no more than the combined thickness of the walls of container
130.
[0052] Referring now to FIG. 5, mechanisms to control the
rotational motion of arms 122 and swivel mounting mechanism 127,
including swivel arms 122, biasing members 125, and biasing member
126 are shown. Specifically illustrated are swivel arms 122 and 128
and the interaction of swivel arms 122 and 128 with support
structure 100 and drums 110a and 110b and biasing members 125 and
126. The illustrated arrows show the direction of force applied by
biasing members 125 and 126 to the various components.
[0053] Swivel arms 122a and 122c are illustrated in FIGS. 6 and 6A.
Rotatable connection point 121a rotatably connects swivel arm 122a
to roller 120a via axle 129a. Rotatable connection point 123
connects swivel arm 122a to drum 110a via connection point 112
(FIG. 4). Cylindrical recession 123.5 has a recessed surface which
is offset from the bottom surface of swivel arm 122a. Connection
point 124 lies in recessed surface 123.5.
[0054] Biasing member 125 is illustrated in FIG. 7. Biasing member
125 has rotatable connection points 125a and 125b. Cylindrical
recession 123.5 of swivel arm 122a is offset from the bottom
surface of swivel arm 122a by a distance sufficient to allow
biasing member 125 to fit between the recessed surface of
cylindrical recession 123.5 and surface 117a of drum 110a as
illustrated in FIG. 5. Connection point 125a couples with
connection point 113 on drum 110a. Connection point 125b couples
with connection point 124 on swivel arm 122a. A second biasing
member 125 is similarly coupled to drum 110b and swivel arm 122c.
Biasing members 125 bias swivel arms 122a and 122c with respect to
drums 110a and 110b such that swivel arms 122a and 122c tend to
rotate counter-clockwise relative to drums 110a and 110b (and drums
110a and 110b tend to rotate clockwise relative to swivel arms 122a
and 122c) with respect to the top plan view of FIG. 5.
[0055] Biasing member 126 is illustrated in FIG. 9 and includes
connection points 126a and 126b. Biasing member 126 is coupled with
swivel mounting mechanism 127, and located between the top surface
of swivel arm 128a and a surface of support structure 100.
Referring to FIG. 5, biasing member 126 engages swivel arm 128a and
support structure 100. Connection point 126a is biased against
support structure 100. Connection point 126b is biased against a
side edge of swivel arm 128a. Biasing member 126 causes swivel
mounting mechanism 127 to tend to rotate counter-clockwise with
respect to the top plan view of FIG. 5. This rotational motion
produces translational motion of drum 110b with respect to support
structure 100.
[0056] Referring now to FIG. 10, one embodiment of flexible
container 130 is shown, including connectors 131a and 131b, gas
expulsion tap 132, mixture expulsion tap 133 and divider 135.
Flexible container 130 is made of any suitable flexible material.
In one embodiment, the container is constructed from two separate,
plastic sheets fused at the edges. In another embodiment, the
container could be one plastic sheet folded and fused at the edges.
The container contains two components. In the illustrated
embodiment, one component is a liquid component, and the other
component is a powder component that is reactive with the liquid
component to form bone cement.
[0057] Divider 135 is a removable divider that partitions the two
components within the common container 130 until such time as
mixing is necessary. Divider 135 in FIG. 10 is shown in one
embodiment as a clip with two elongated members that extend along
either side of flexible container 130 and apply pressure to
flexible container 130 and against each other. The pressure creates
a seal within flexible container 130 that prevents one component in
one side or compartment of container 130 from physically accessing
the other component in the other side or compartment of container
130. When divider 135 is removed, the two components have fluid
access to each other.
[0058] Gas expulsion tap 132 is fluidly connected to the inside of
flexible container 130. Gas expulsion tap 132 can be of a luer lock
connection type, and may be operable to expel gases from the
flexible container when properly oriented. During mixing, gases can
be created as a by-product of a chemical reaction between the
reactive components within flexible container 130. Gases also are a
residual component of dead space within the powder component. The
gases can optionally be expelled via tap 132 into a large capacity
syringe, a fume hood or a vacuum device. In any event, whether
gasses are expelled from flexible container 130 or retained in
flexible container 130, such gasses can optionally be kept isolated
from the surrounding environment such as a surgery room. This can
be advantageous if the gasses have some undesirable characteristics
such as being malodorous and/or noxious.
[0059] Mixture expulsion tap 133 is fluidly connected to the inside
of flexible container 130. Mixture expulsion tap 133 can of be a
luer lock connection type, and may be used to dispense a mixture
from the flexible container when properly oriented. This allows
bone cement to be expelled into a medical syringe or other
appropriate application device. In the illustrated embodiment
mixture expulsion tap 133 is located on the bottom side of the
container. However, in other embodiments, tap 133 could be located
on the top side of the container. The functional descriptions of
taps 132 and 133 are dependent upon the orientation of container
130. Either tap can be used for any purpose described herein.
Alternatively, flexible container 130 could have only one tap that
is operable for both expelling gas, and dispensing mixture. The
location of either one or both taps on the container can vary. For
example one or both taps could be located at either ends of
flexible container 130.
[0060] Flexible container 130 can be pre-filled with two components
for eventual mixing into a cement compound, e.g. one component in
each of the separated compartments of container 130. In another
embodiment, the components can be added through either of the taps
132 or 133 after divider 135 is in place. In yet another
embodiment, the components could be added through the ends of the
container, and then subsequently the ends of the container could be
sealed.
[0061] Connector 131 may refer to either and/or both connectors
131a and 131b, which are constructed and arranged to connect
flexible container 130 to drums 110a and 110b. Coupling channel 111
on drums 110a and 110b may be shaped with an elongated opening
width that is less than the maximum channel width. Connector 131
can be a rigid or semi-rigid elongated member with a width or
diameter that is greater than the elongated opening width of
coupling channel 111. Flexible container 130 can be connected to
drum 110a by sliding connector 131 into coupling channel 111 in the
axial direction (i.e. along the axis of connector 131) until
connector 131 abuts against channel end 118 (FIG. 4), thus allowing
the material of flexible container 130 to pass through the
elongated opening of channel 111, but restricting connector 131
from passing through the elongated opening of channel 111. Such a
connection may allow roller 120a to pass over coupling channel 111
when flexible container 130 is connected without requiring
excessive displacement of roller 120a with respect to swivel arms
122a and 122c, or without requiring adjustment of the length of
swivel arms 122a and 122c. It should be apparent that other
connection parts or structures would be equally suitable.
[0062] Referring now to FIGS. 11-15, motion-producing mechanism 144
is illustrated, including crank 104, connecting arm 105, gear
reducer 106, electric motor 107, and guide channel 108.
Motion-producing mechanism 144 as illustrated in FIGS. 11-15
operates as a kinematic linkage with connecting arm 105 as a
linking member. Crank 104 is situated in support structure 100 and
interacts with connecting arm 105 as shown in FIGS. 11 and 14.
Crank connection point 104a is rotatably coupled with connection
point 105a. Channel guide 105c is slidingly positioned within guide
channel 108 on support structure 100. Connection point 105b is
rotatably coupled with connection point 114 on drum 110a (FIG.
4).
[0063] Rotation of crank 104 generates reciprocating rotation of
drum 110a through the kinematic linkage provided by connecting arm
105. In the illustrated embodiment, as crank 104 is rotated through
180 degrees, connecting arm 105 causes drum 110a to rotate 90
degrees. Continued rotation of crank 104 through an additional 180
degrees (in the same direction) causes drum 110a to rotate 90
degrees in the opposite direction. Thus, rotation of crank 104
through a 360 rotation generates reciprocating rotation of drum
110a through 90 degrees in one direction and 90 degrees in the
opposite direction. It should be noted that guide channel 108 is
not necessary to achieve the described motion; however it can
support both connecting arm 105 and drum 110a with respect to
support structure 100.
[0064] Crank 104 can be a hand crank or other motorized means. FIG.
12 shows one embodiment whereby electric motor 107 drives gear
reducer 106 which drives crank 104. In this embodiment, gear
reducer 106 reduces the rotational speed of the motor and creates
greater torque power applied at crank connection point 104a.
[0065] In other embodiments, motion-producing mechanism 144
described above can be achieved using any suitable means in
addition to the described embodiment. For example, belts or gears
(not pictured) could be used to create motion of drum 110a, whereby
crank 104 could be attached to drum 110a via a belt or chain. In
such an embodiment, crank 104 and drum 110a could be fixed with a
pulley or gear suitable to receive the belt or chain. In this way,
rotating motion of crank 104 would cause linear, translational
motion of said belt or chain which would interact with the pulley
or gear fixed to drum 110a, resulting in rotational motion of drum
110a. Reciprocating motion of drum 110a could be achieved by
alternately changing the direction of crank 104.
[0066] Alternatively, crank 104 and drum 110a could be fixed with
mated gears (not pictured) such that rotational motion of crank 104
causes rotational motion of a gear fixed to crank 104, resulting in
rotational motion of a gear fixed to drum 110a and simultaneous
rotational motion of drum 110a. Reciprocating motion of drum 110a
could be achieved by alternately changing the direction of crank
104.
[0067] Use of any of the above discussed means to mix the contexts
in flexible container 130 may result in a mixing system that
produces consistent mixing characteristics. For example, operating
a motorized crank 104 for a period of time or manually revolving
crank 104 a set number of times may result in consistently mixing
the components contained in flexible container 130 such that a
manufacturer could specify mixing parameters in a way that is
consistently repeatable. This could be important in some
applications because some reactive mixtures have a limited period
of time in which they can be administered. Spending excessive time
mixing the reactive components may reduce the time available to
administer them. Consistent mixing of reactive components may
improve application results because the reactive mixture will be
consistently adequately mixed and the amount of time available to
administer the reactive mixture may be well defined. Consistent
mixing also improves batch to batch consistency when multiple
mixtures may be required.
[0068] Referring now to FIGS. 16A-17C, several embodiments of the
interaction of flexible container 130 with the mixing device are
illustrated. FIG. 16A shows mixing device 99 with drums 110,
rollers 120, swivel arms 122, swivel mounting mechanism 127,
retaining arms 101a and 101b, and handles 102a and 102b. FIG. 16B
shows mixing device 99 in a condition that is ready for flexible
container 130 to be mounted with swivel arms 122 being biased and
restrained in position by retaining arms 101.
[0069] Retaining arm 101a and handle 102a are attached to support
103a. Support 103a is rotatably coupled with support structure 100
such that handle 102a is above the top surface of support structure
100 and retaining arm 101a is below the top surface of support
structure 100. When handle 102a is pivoted around the location of
support 103a, retaining arm 101a simultaneously pivots around the
location of support 103a.
[0070] Retaining arm 101b and handle 102b are attached to support
103b. Support 103b is rotatably coupled with support structure 100
such that handle 102b is above the top surface of support structure
100 and retaining arm 101b is below the top surface of support
structure 100. When handle 102b is pivoted around the location of
support 103b, retaining arm 101b simultaneously pivots around the
location of support 103b.
[0071] The position of drum 110a is rotatably controlled by
connecting arm 105 and crank 104 (FIG. 11). Biasing member 125
(FIG. 5) biases swivel arm 122a with respect to drum 110a to
position roller 120a near the center area of support structure 100.
In FIG. 16B, swivel arm 122a is rotated clockwise and against the
biasing force of biasing member 125. Retaining arm 101a is pivoted
around support 103a and retaining arm 101a abuts axle 129a to hold
swivel arm 122a in place against the bias of its member 125.
[0072] Drum 110b can be rotatably and temporarily fixed in place by
applying manual pressure to an external surface of drum 110b, such
as surface 116a. Biasing member 125 (FIG. 5) biases swivel arm 122c
with respect to drum 110b. In FIG. 16B, swivel arm 122c is rotated
clockwise and against the biasing force of biasing member 125.
Retaining arm 101b is pivoted around support 103b and retaining arm
101b abuts axle 129b to hold swivel arm 122c in place against the
bias of its member 125.
[0073] In the configuration of FIGS. 16C and 17A, flexible
container 130 is mounted to drums 110a and 110b via exposed
coupling channels 111 on both drums without interference by either
swivel arms 122 or rollers 120 and while one or both of drums 110a,
110b are held in position by their respective arms 101a, 101b.
Flexible container 130 is inserted into the mixing device, and
connector 131a is inserted into coupling channel 111 of drum 110a
until connector 131a abuts channel end 118 of drum 110a, while
connector 131b is inserted into coupling channel 111 of drum 110b
until connector 131a abuts channel end 118 of drum 110b.
[0074] In FIGS. 16C and 17A, divider 135 is attached to flexible
container 130. In FIGS. 16D and 17B, divider 135 is removed and
handles 102a and 102b are moved to disengage retaining arms 101a
and 101b from swivel arms 122a and 122c. With divider 135 removed,
the cement components in flexible container 130 can come together
to mix, and both components are forced towards the center of
flexible container 130 between the connection points of roller 120a
and drum 110a, and roller 120b and drum 110b, as shown in FIG. 17B.
Swivel arms 122a and 122c rotate counter-clockwise towards the
center of support structure 100. Simultaneously, drum 110b rotates
clockwise, applying a lateral tensile force to flexible container
130. Biasing member 126 causes drum 110b to apply pressure to the
surface of flexible container 130 and against drum 110a.
[0075] The offset distances between outer-drum surfaces 116 and
inner drum surfaces 117 are configured and arranged to allow
adequate clearance for swivel arms 122 to pass over and below
expulsion taps 132 and 133. Similarly, the offset distances between
swivel arms 122 and rollers 120 are configured and arranged to
allow sufficient clearance for taps 132 and 133.
[0076] It should be appreciated that means other than biasing
members 125 could be used to maintain the rotational relationship
between drums 110a and 110b, such as gears or kinematic
linkages.
[0077] Mixing is achieved by alternating clockwise and
counter-clockwise 90 degree rotations of drum 110a and forcing
movement of the components within flexible container 130 from one
area of flexible container 130 to another area of flexible
container 130 due to the surface pressure applied by rollers 120a
and 120b on flexible container 130 acting against drums 110a and
110b.
[0078] FIG. 17C shows the location of flexible container 130 after
a 90 degree counter-clockwise rotation of drum 110a. The components
are moved from one area of flexible container 130 to another area
of flexible container 130, e.g. each cement component moves toward
the other and toward the middle of container 130. The mixing
process is continued by rotating drum 110a 90 degrees clockwise
back to the state depicted in FIG. 17B, and the process is repeated
until the components are sufficiently mixed, or until gas purging
is necessary. FIG. 16D is a perspective view of the mixing device
in the state depicted in FIG. 17B.
[0079] It should be appreciated that the interaction of rollers 120
on drums 110 could be achieved by other suitable embodiments. For
example, pressure surface 115 of drums 110a and 110b could be
non-cylindrically curved, such that rotatable connection point 123
of swivel arms 122 does not coincide with a circular center-point
axis corresponding to pressure surface 115. In such case swivel
arms 122 could be integrated with a biasing member to allow a
differential distance between rotatable connection point 123 and
rotatable connection point 121. Such biasing member could also be
used to vary the pressure forces between rollers 120 and drums
110.
[0080] Referring now to FIG. 18, a cross-section of one embodiment
of flexible container 130 is illustrated, including interior fused
surfaces 134, narrowed flow channels 136a and 136b, chambers 137a
and 137b, and rounded chamber walls 138a and 138b. The internal
chamber of flexible container 130 is generally bisected by interior
fused surfaces 134, creating chambers 137a and 137b.
[0081] In one embodiment, interior fused surfaces 134 may be
created by externally applying heat to one or both surfaces or
plies of flexible container 130, essentially creating a weld that
acts as an internal wall subdividing flexible container 130 into
multiple chambers. In other embodiments, interior fused surface 134
may be created by any known welding or bonding technique.
Alternatively, interior fused surfaces 134 could be created by
inserting and attaching additional flexible material between the
two surfaces of flexible container 130. Rounded chamber walls 138a
and 138b could be similarly created by externally applying heat to
one or both surfaces of flexible bag 130 to fuse the surfaces
together. In the illustrated embodiment, flexible container 130 is
constructed and arranged to have narrowed flow channel 136a that
feeds into mixing chamber 137a, and narrowed flow channel 136b that
feeds into mixing chamber 137b.
[0082] Connectors 131a and 131b can be created by attaching an
elongated rigid structure to the ends of flexible container 130 by
adhesive. Alternatively, connectors 131a and 131b can be created by
wrapping either end of flexible container 130 around an elongated
rigid structure and attaching the flexible material back against
itself. Alternatively, connectors 131a and 131b can be created by
rolling an elongated rigid structure into either end of flexible
container 130.
[0083] Generically-depicted divider 135a is located in the
configuration of FIG. 18 to isolate mixing chamber 137a from mixing
chamber 137b. While a mechanical divider is illustrated, any
technique to divide mixing chamber 137a and 137b may be used,
including, but not limited to, weak internal bonding of interior
surfaces. Gas expulsion tap 132 may be fluidly-connected with one
mixing chamber, while mixture expulsion tap 133 is
fluidly-connected with the other mixing chamber in the case where
the two mixing components are loaded into the flexible container
through the taps. However, if the flexible container is loaded in a
different manner, such as through unsealed edges, the taps need not
correspond with separate isolated mixing chambers.
[0084] Referring now to FIGS. 19A through 20B, the interaction of
rollers 120 with flexible container 130 to achieve mixing and
expulsion of both gas and mixture is illustrated. In FIG. 19A,
divider 135 has been removed, allowing previously isolated liquid
and powder components to be in fluid communication with each other.
FIGS. 19A and 19B illustrate the reciprocal motion of flexible
container 130 provided by the driving motion of drum 110a, as
discussed previously.
[0085] FIG. 19A corresponds to the transition from the state
depicted in FIG. 17C to the state depicted in FIG. 17B. As drum
110a rotates clockwise, flexible container 130 moves to the left
with respect to rollers 120a and 120b. Roller 120b is positioned
away from narrowed flow channel 136b, allowing fluid access of the
mixture in mixing chamber 137a to mixing chamber 137b via narrowed
flow channel 136b.
[0086] Simultaneously, as drum 110a rotates clockwise, a pinch
point between roller 120a and drum 110a seals off narrowed flow
channel 136a and the corresponding fluid access between mixing
chambers 137a and 137b. As continued rotation of drum 110a moves
flexible container 130 to the left, the pinch point between roller
120a and drum 110a in mixing chamber 137a forces the mixture
contained in mixing chamber 137a through narrowed channel 136b and
into mixing chamber 137b.
[0087] Narrowed channel 136b serves as a mixing catalyst by
increasing shear separation due to fluidly developed boundary
layers occurring near the walls of narrowed channel 136b. Due to
surface friction, the mixture closest to the wall flows at a
reduced speed compared to the mixture nearest the center of
narrowed chamber 136b. This results in many layers of shear flow
separation within the fluid that enhance mixing as the mixture is
forced through narrowed channel 136b.
[0088] Additionally, the mixture moves from narrowed channel 136b
into mixing chamber 137b with an increased flow rate compared to
any flow rate or motion within either mixing chamber 137a or 137b.
Rounded chamber wall 138b guides the higher flow rate mixture into
a swirling motion that intermixes with slower flow rate mixture in
mixing chamber 137a. Again, the differential flow rates cause shear
mixing to occur. In the illustrated embodiment, rounded chamber
walls 138a and 138b are devoid of any corners that could cause any
material to become stuck, or stagnate in one area.
[0089] When drum 110a has completed a full 90 degree rotation and
flexible bag 130 has moved sufficiently far enough to the left that
a substantially large portion of the mixture is contained in mixing
chamber 137b, the motion of drum 110a is halted and reversed, and a
reciprocal process begins. FIG. 19B illustrates the reciprocal
process to that previously described, and corresponds to the
transition from the state depicted in FIG. 17B to the state
depicted in FIG. 17C.
[0090] Once the mixture is sufficiently uniform, drum 110a is
returned to or halted in a pre-determined position, for example,
the drum and roller configuration depicted in FIG. 17C, a gas
expulsion process may begin. Gas expulsion tap 132 may be connected
to a vacuum device or placed in a fume hood that is suitable to
isolate any fumes from the operating theatre. Alternatively, gas
can be expelled directly into the operating theatre. Mixing device
99 and flexible container 130 can be oriented such that the gas
expulsion tap 132 is vertically oriented at the highest elevation
point of flexible container 130. Gas expulsion tap 132 is opened,
and gas is allowed to escape from mixing chamber 137b through the
tap (FIG. 20A). Biasing member 125 on swivel arm 122c causes roller
120b to apply pressure against flexible container 130 to cause gas
to flow through gas expulsion tap 132. As gas is lighter than the
mixture, the gas will naturally move towards the top edge of
flexible container 130, and substantially all of the gas can be
expelled.
[0091] Once the gas is expelled, or when a small amount of mixture
is expelled through gas expulsion tap 132, gas expulsion tap 132
may be closed, and a mixture expulsion process can begin. Mixture
expulsion tap 133 may be connected to a syringe or other suitable
device, and mixture expulsion tap 133 is opened. Biasing member 125
coupled with swivel arm 122a causes roller 120a to apply pressure
against the mixture contained in mixing chamber 137a (FIG. 20B).
Because narrowed flow channel 136b is closed by external pressure
from roller 120b, the only path for the mixture is through mixture
expulsion tap 133. The mixture can be expelled until the syringe or
other device is filled, or until the substantially entire amount of
mixture is expelled from flexible container 130. In this way,
rollers 120a and 120b serve to both mix the mixture in flexible
container 130 and to expel the mixture from flexible container 130.
Furthermore, after use, flexible container 130 continues to contain
any residual mixture not expelled, simplifying the disposal of the
mixture. In the event that all of the mixture is expelled, flexible
container 130 is reduced to a substantially flat, flexible object
that is easily disposed, taking up minimal disposal space.
[0092] It should be understood that the mixing, gas expulsion, and
mixture expulsion processes need not be performed in precisely the
order presented here. For example, it may be prudent or necessary
to expel gas and then continue the mixing process. Also for
example, it may be prudent or necessary to continue the mixing
process even after some mixture has been expelled.
[0093] Referring now to FIG. 21, an alternative mechanical
embodiment of divider 135 is shown. Divider 135b consists of rod
139a having rod width 142, and c-clip 139b having internal width
140 and opening width 141. Internal width 140 is greater than
opening width 141. C-clip 139b can be partially cylindrical, having
a circumference that is greater than 180 degrees. Rod 139a is
substantially rigid and has rod width 142 which is greater than
opening width 141. C-clip 139a is formed of a semi-rigid, yet
sufficiently compliant material to allow rod 139a to be inserted
into c-clip 139b through opening width 141.
[0094] FIG. 22 depicts an alternative embodiment of flexible
container 130 having internal flow channel 143 and chambers 137a
and 137b. Flow channel 143 fluidly connects chambers 137a and 137b.
When mixture flows from one chamber to the second chamber, flow
channel 143 provides a narrowing and increased flow rate of the
mixture during mixing that may serve to enhance mixing of the
components contained in chambers 137a and 137b.
[0095] FIG. 22 depicts dividers 135b being engaged in two places
with flexible container 130, such that the flexible material of
flexible container 130 is positioned between rod 139a and c-clip
139b when rod 139a is inserted into c-clip 139b. Rod width 142 is
sufficiently close to internal width 140 such that surface pressure
is applied between rod 139a and c-clip 139b and against flexible
container 130. The surface pressure is sufficient to create an
internal seal within flexible container 130 such that two chambers
are formed that do not have fluid access with each other, until
such time as dividers 135b are disengaged. As depicted in FIGS. 21
and 22, rod 139a can be longer than c-clip 139b.
[0096] Referring now to FIGS. 23A and 23B, two alternative
embodiments of flexible container 130 are presented. FIG. 23A shows
flexible container 130 with taps 132 and 133 vertically aligned,
and generically-depicted divider 135a being angularly offset. FIG.
23B shows flexible container 130 with taps 132 and 133 being
vertically offset, and generically-depicted divider 135a being
vertically aligned. It should be appreciated that there are many
possible (non-illustrated) configurations of taps and dividers.
Variations in consistency, thixotropy, viscosity, etc., could make
one type of divider more suitable for a particular material.
[0097] Referring now to FIGS. 24 and 25, two alternative
embodiments of flexible container 130 are shown. FIG. 24 shows
flexible container 130 with interior fused surface 134a. Interior
fused surface 134a is shaped with the middle section being wider
then the end sections. FIG. 25 shows flexible container 130 with
interior fused surface 134b. Interior fused surface 134b is shaped
with the middle section being narrower than the end sections. It
should be appreciated that there are many possible
(non-illustrated) configurations and shapes of internal fused
surfaces.
[0098] While the disclosure has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiments have been
shown and described and that all changes and modifications that
come within the spirit of the disclosure are desired to be
protected.
* * * * *